Xtracare Vaporizing Chest Rub
Camphor, Menthol
Rejoice International
Human Otc Drug
NDC 57337-051Xtracare Vaporizing Chest Rub also known as Camphor, Menthol is a human otc drug labeled by 'Rejoice International'. National Drug Code (NDC) number for Xtracare Vaporizing Chest Rub is 57337-051. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Xtracare Vaporizing Chest Rub drug includes Camphor (natural) - 5 g/113g Menthol - 1 g/113g . The currest status of Xtracare Vaporizing Chest Rub drug is Active.
Drug Information:
| Drug NDC: | 57337-051 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Xtracare Vaporizing Chest Rub |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Camphor, Menthol |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rejoice International |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CAMPHOR (NATURAL) - 5 g/113g
MENTHOL - 1 g/113g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 30 Jan, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part341 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Rejoice International
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1487908
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0849607059291
|
| UPC stands for Universal Product Code. |
| UNII: | N20HL7Q941
L7T10EIP3A
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 57337-051-01 | 113 g in 1 BOTTLE (57337-051-01) | 30 Jan, 2014 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Uses on chest and throat, temporarily relieves cough as may occur with common cold and minor bronchial irritation. for the temporary relief of pain associated with minor skin irritation.
Product Elements:
Xtracare vaporizing chest rub camphor, menthol cedar leaf oil nutmeg oil petrolatum thymol turpentine oil camphor (natural) camphor (natural) menthol menthol
Indications and Usage:
Xtracare® vaporizing chest rub cough suppressant net wt 4 oz (113 g)
Warnings:
Warnings for external use only; avoid contact with eyes. do not use by mouth in nostrils on wounds or damaged skin with tight bandages ask a doctor before use if you have cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma or emphysema when using this product, do not heat microwave add to hot water or any container where heating water. may cause splattering and result in burns. stop use and ask a doctor if muscle aches and pains persist more than 7 days or come back cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. these could be signs of a serious condition. if pregnant or breast-feeding , ask a health professional before use.
Dosage and Administration:
Directions see important warnings under "when using this product" adults and children 2 years old and older: rub a thick layer on chest & throat or rub on sore aching muscles cover with a warm, dry cloth if desired keep clothing loose about throat chest to help vapors reach the nose/mouth repeat up to three times per 24 hours or as directed by doctor children under 2 years: do not use
Package Label Principal Display Panel:
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